BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2991571 · Received March 6, 2013

    Report

    Report Number
    2024168-2013-01303
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 12, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED NEEDLE-TO-CUFF MISS WAS NOT CONFIRMED AS ANALYSIS OF THE DEVICE INDICATED THAT THE LINK BROKE FROM THE POSTERIOR END OF THE POSTERIOR CUFF, WHICH HAS THE SAME CHARACTERISTICS TO THE OPERATOR AS A NEEDLE-TO-CUFF MISS. BASED ON VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE PATIENT WAS REPORTEDLY MORBIDLY OBESE WITH A DEEP TISSUE TRACT. THE PERCLOSE PROGLIDE DEVICE INSTRUCTIONS FOR USE UNDER THE SPECIAL PATIENT POPULATIONS SECTION STATES THAT THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENT POPULATIONS WHO ARE MORBIDLY OBESE WITH A BODY MASS INDEX GREATER THAN (B)(4). THE OTHER PERCLOSE PROGLIDE DEVICES, REFERENCED ARE FILED UNDER SEPARATE MEDWATCH MANUFACTURER REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN ABDOMINAL AORTIC ANEURYSM REPAIR PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ATTEMPTED OF THE COMMON FEMORAL ARTERY USING PERCLOSE PROGLIDE DEVICES THROUGH A 7-FRENCH SIZED ACCESS SITE. REPORTEDLY, DURING DEPLOYMENT OF THE FIRST PROGLIDE DEVICE, A NEEDLE-TO-CUFF MISS OCCURRED. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND TWO ADDITIONAL PROGLIDE DEVICES WERE ATTEMPTED, BUT ALSO RESULTED IN A NEEDLE-TO-CUFF MISSES. THE ACCESS SITE WAS UPSIZED TO AN 18-FRENCH SIZED SHEATH, AND AFTER CONCLUSION OF THE ABDOMINAL AORTIC ANEURYSM REPAIR PROCEDURE, THE ACCESS SITE WAS SURGICALLY SUTURED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE INDEX PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94686 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21102J2

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SHEATH: 7-FRENCH